MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., 18 X 3/32 FEMORAL EYELOOP DRILL (BOX OF 6); BIT, DRILL

Catalog Number	234-020-051
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the tip broke and remained in the bone.
Additional Manufacturer Narrative
Alleged failure: acl femoral guide wire 2.4mm eyeloop drill 18" was used in acl case for dr.(b)(6) on (b)(6) 2019.The eyeloop drill broke during the procedure & left the tip of femoral drill inside the bone.An x-ray was taken immediately to confirm the positioning of broken piece.There is procedure delay for around 20-30 minutes, ie.Moving x-ray machine , screening and locating the broken piece¿.No x-ray screen shot is available for investigation due to confidential issues.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be excessive force applied on device.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
Event or Problem Description
It was reported that the tip broke and remained in the bone.

• Brand Name: PKG., 18 X 3/32 FEMORAL EYELOOP DRILL (BOX OF 6)
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8708424
• Report Number: 0002936485-2019-00239
• Device Sequence Number: 19429928
• Product Code: HTW
• UDI-Device Identifier: 34546540755545
• UDI-Public: 34546540755545
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 234-020-051
• Device Lot Number: 3781908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other